Introducer for uterine tamponade assembly with echogenic element and methods of using the same

ABSTRACT

A device for use with a uterine tamponade balloon catheter apparatus, such as the Bakri postpartum hemorrhage balloon, is disclosed. The device comprises a stylet comprising a hub at its proximal end and an atraumatic tip at its distal end. The device is configured to be removably coupled to the tamponade balloon catheter apparatus to aid in the insertion and positioning of the tamponade balloon catheter within the uterine cavity, allowing the balloon to function as intended for the control and management of postpartum hemorrhage and uterine bleeding. The tamponade balloon catheter includes an echogenic element to aid in visualization by ultrasound during insertion and use. Methods of use of the device are also disclosed.

RELATED APPLICATIONS

This application is a continuation application of U.S. patentapplication Ser. No. 16/570,034, filed Sep. 13, 2019, which claims thebenefit of the filing date under 35 U.S.C. § 119(e) of Provisional U.S.Patent Application Ser. No. 62/734,422, filed Sep. 21, 2018, which arehereby incorporated by reference in their entireties.

TECHNICAL FIELD

The present invention relates generally to apparatus and methods forcontrolling uterine bleeding, and more specifically, to an accessorydevice for use with a uterine tamponade assembly that facilitates properinsertion and positioning of the tamponade assembly within the uterus.The present invention also relates generally to an echogenic componentfor the uterine tamponade assembly to assist in visualizing andpositioning the assembly by ultrasound during use.

Uterine bleeding is a clinical condition attributable to a variety ofcauses, including postpartum hemorrhages (PPH) following vaginal and/orcesarean childbirth. Postpartum hemorrhage or excessive blood loss afterchildbirth is commonly caused by uterine atony whereby the uterus failsto contract normally after the delivery of a baby, leading to continuousbleeding. If left untreated, PPH may cause serious complications or evendeath.

There are a variety of techniques used for treating and managing PPH,including the administration of muscle contracting drugs or agents aloneor in combination with other mechanical or surgical techniques. One suchtechnique includes inserting a tamponade apparatus such as a balloontamponade catheter into the uterus, wherein the balloon is inflated to asufficient pressure and volume until it conforms generally to thecontour of the lower uterine segment. The application of pressure to theinterior uterine wall provides a tamponade effect until bleeding iscontrolled or stopped. One example of a uterine tamponade ballooncatheter is the Bakri balloon, Cook Medical Technologies LLC,Bloomington, Ind. The effectiveness of the Bakri balloon may bepartially attributable to efficient and proper insertion, placement andinflation, as well as maintaining the balloon in a proper positionwithin the uterine cavity.

In most cases, when use of a balloon tamponade catheter is required, thephysician may insert the balloon portion of the catheter into theuterus, making certain that the entire balloon is inserted past thecervical canal and internal ostium. Insertion may be accomplishedtrans-vaginally following vaginal delivery or trans-abdominallyfollowing a cesarean delivery. It is therefore desirable to provide anaccessory device, such as an introducer, that can remain in place duringuse and also serve as a positioner to maintain the proper positioning ofthe balloon tamponade catheter, which can be used efficiently,effectively, and accurately insert and position the balloon tamponadecatheter within a patient's uterus. It is also desirable to provide theballoon tamponade catheter with an echogenic component or element toassist the physician with visualization and placement of the balloontamponade catheter within the uterus. Accordingly, the disclosedintroducer device and/or the disclosed echogenic component can be usedwith various known uterine tamponade assemblies, such as the Bakriballoon.

The disclosed introducer device may be utilized to rapidly introduce thetamponade assembly into the uterus and remain in place during use of thetamponade assembly. This may allow the balloon to function as intendedfor the control and management of PPH and uterine bleeding.Advantageously, the disclosed introducer device may therefore provide adesired combination of attributes and characteristics, including, butnot limited to, flexibility, torsion and malleability to navigate apatient's anatomy without causing trauma, while also having sufficientpushability and column strength to aid in insertion of the tamponadeassembly and allowing adequate drainage if left in place during use ofthe tamponade balloon assembly. Further, the disclosed echogeniccomponent can provide improved visualization during insertion and assistwith accurate positioning and placement of the tamponade assembly in theuterus.

SUMMARY

In one example, the present disclosure describes a positioning devicecomprising a stylet comprising a longitudinal body having a proximal endand a distal end. A hub is located at the proximal end of the stylet.The hub comprises a proximal end, a distal end and a sidewall extendingthere between defining a hub lumen, wherein the sidewall comprises afirst portion having a first thickness and a second portion comprising asecond thickness, wherein the second thickness is greater than the firstthickness, and wherein the stylet is coupled to the second portion.

In another example, a catheter assembly is described. The catheterassembly comprises a positioning device comprising a stylet having aproximal end and a distal end and a hub at the proximal end of thestylet. The assembly further comprises a tamponade balloon cathetercomprising a catheter having a proximal end and a distal end and atleast one lumen extending there between, wherein the catheter comprisesat least one echogenic element disposed thereon. The assembly furthercomprises an expandable tamponade device disposed about at least aportion the catheter. The stylet is configured to extend longitudinallywithin at least a portion of the at least one catheter lumen.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of a patient's anatomy showing trans-vaginalinsertion and inflation of one example of a tamponade balloon catheterwith an example of an introducer device coupled to the tamponade ballooncatheter and a drainage assembly coupled to the tamponade ballooncatheter.

FIG. 2 is an enlarged view of the distal end of the tamponade ballooncatheter of FIG. 1 having one example of an echogenic element.

FIG. 3 illustrates the visualization of the distal tip of a plurality oftamponade balloon catheter assemblies by ultrasound, with each tiphaving varying amounts of echogenicity.

FIG. 4 is a perspective view of one example of an introducer device,including a hub and a stylet extending from the hub.

FIG. 5 is a side view of one example of an introducer device comprisinga hub and stylet extending from the hub.

FIG. 6 is a side cross-sectional view of one example of the proximal endof a tamponade balloon catheter with a hub and stylet removably coupledthereto, and a drainage tube removably coupled to the proximal end ofthe hub.

FIG. 7 is a cross-sectional view of one example of a tamponade ballooncatheter shown in FIG. 6 .

FIG. 8 illustrates trans-abdominal insertion of one example of atamponade balloon catheter.

FIG. 9 is a perspective view of one example of an introducer deviceincluding a hub and a stylet with an atraumatic distal tip attached tothe hub.

FIG. 10 is an enlarged view of the atraumatic distal tip of the styletof FIG. 9 .

FIG. 11 is an enlarged view of the proximal end of one example of atamponade balloon catheter with the side arm thereof inserted into theproximal end of one example of a hub of an introducer device.

DETAILED DESCRIPTION

Throughout this specification, the terms proximal and proximally areused to refer to a position or direction away from, or even external toa patient's body and the terms distal and distally are used to refer toa position or direction towards the patient and/or to be inserted into apatient's body orifice or cavity. The embodiments described below are inconnection with an introducer device for use with, or as an accessoryto, a tamponade assembly such as a tamponade balloon catheter fortreating postpartum hemorrhage, and for introducing and positioning thetamponade balloon catheter in a desired position within the uterus.However, the described introducer device may also be used in connectionwith a range of medical instruments which are inserted into various bodycavities to effectively and efficiently introduce and position suchinstruments depending on the technique or procedure being performed aswill be appreciated by those of skill in the art. The embodimentsdescribed below are also in connection with an echogenic element for atamponade balloon catheter to assist with visualization of the tamponadeassembly during the insertion, positioning and placement within theuterus.

FIG. 1 illustrates one example of a tamponade assembly, or tamponadeballoon catheter assembly 2, inserted and positioned within a patient'sanatomy. The balloon is shown in an inflated state in solid lines, andthe deflated state is represented by the phantom lines of FIG. 1 . Apositioning or introducer device 12 extends into the proximal end 13 ofthe lumen of the tamponade balloon catheter assembly 2. A drainage tube44 is removably attached to the proximal end of the introducer device 12leading to a collection bag 11.

Tamponade, which is the closure or blockage of a wound by applyingdirect pressure to the source of bleeding, is a useful method ofstopping or managing bleeding or hemorrhage. One example of a knowntamponade assembly includes a Bakri balloon catheter (Cook MedicalTechnologies LLC, Bloomington, Ind.). The tamponade balloon catheterassembly 2, i.e., a Bakri balloon catheter, is shown as being expandedwithin the uterine cavity. An introducer device 12 extends within thelumen of the tamponade balloon catheter assembly 2. The introducerdevice 12 can remain within the lumen of the tamponade balloon catheterassembly 2, therefore also serving as a positioner to maintain thetamponade balloon catheter assembly 2 in place, allowing the user toreposition the tamponade balloon catheter assembly 2 during use.

As indicated by the arrow in FIG. 1 , the introducer device 12 can beused to insert the tamponade balloon catheter assembly 2 vaginallyfollowing a vaginal birth. Alternatively, as illustrated in FIG. 8 , theintroducer device 12 can be employed to introduce the tamponade ballooncatheter assembly 2 trans-abdominally following a cesarean birth. Asshown by the arrow in FIG. 8 , the introducer device 12, coupled withthe tamponade balloon catheter assembly 2, can be introduced through thecesarean opening in the patient's abdominal wall and into the uterus 4.The proximal end 13 of the tamponade balloon catheter assembly 2 canthen be pulled through the vaginal canal until the base of the balloon 6(which is in a deflated state in FIG. 8 ) contacts the internal cervicalostium. Before inflation of the tamponade balloon catheter assembly 2,the incision may be closed, being careful not to puncture the uninflatedballoon 6 while suturing.

While the tamponade balloon catheter assembly 2 is intended forplacement in the uterine cavity 4 of a patient for treating andcontrolling postpartum hemorrhage (PPH), it may also be used in variousother locations, lumens or orifices within the body, including vessels,bones, organs or other tissues, as necessary or desired. Its dimensionsare alterable so that it may be appropriately dimensioned to navigate tothe uterus 4, or any other target body cavity, from which fluid, such asblood, will be drained. As shown in FIG. 1 , the tamponade ballooncatheter assembly 2 preferably includes a catheter 8 having alongitudinal body 9 and a distal end 15 and a proximal end 13.

There is a drainage lumen 16 extending along the length of thelongitudinal body 9 between the proximal 13 and distal 15 ends and, inone example, a connector (such as a Y-connector or any other suitableconnector) may be located at the proximal end 13 of the catheter 8 forconnecting the catheter 8 to a source of air or saline for inflation ofthe balloon 6 and/or for connecting the catheter 8 to a collection bag11 or receptacle for receiving waste, fluid and/or blood drained fromthe patient. The catheter 8 may include one or more openings 17 at ornear its distal end 15, such that when the distal end 15 of the catheter8 is positioned in the uterus 4, the openings 17 allow blood and otherfluids to enter and flow through the drainage lumen 16. The drainagelumen 16 may also be used to introduce irrigation fluid or othermaterial into the uterus 4, such as to flush the openings 17 at thedistal end 15 of the catheter 8 should they become blocked with clottedblood, tissue or other debris. The catheter 8 may also includeadditional ports or orifices at various points along the longitudinalbody 9 to allow blood or other fluid to enter the catheter 8. Thecatheter 8 may also be provided with one or more depth markers on and/oralong the length of the shaft to further aid in positioning andplacement. For example, as shown in FIG. 1 , a plurality of lines, ringsor other similar types of markings are located at several spaced apartlocations along the catheter, identified with measurements such as “XXcm” for example. Such markings provide a visual indication to thephysician regarding the distance of measure, length and/or depth ofinsertion and position of the catheter 8 within the uterus.

As shown in FIG. 2 , the catheter 8 may include one or more componentsthat assist and/or enhance visualization of at least part of thetamponade balloon catheter assembly 2. In one example, this may includeproviding the tamponade balloon catheter assembly 2 with an echogenicstructure or element 19. An echogenic element 19 may include anystructure that enhances visualization of one or more portions of thetamponade balloon catheter assembly 2. The echogenic element may then beviewed via ultrasound, such as by an ultrasound device, transducer orwand 21 as shown in FIG. 1 . More specifically, echogenicity is theability to bounce an echo, or return a signal in ultrasoundexaminations. Echogenicity is higher when the surface bouncing the soundecho reflects the sound waves. Tissues or elements that have higherechogenicity are usually represented with lighter colors on images inmedical ultrasonography. In contrast, tissues or elements with lowerechogenicity are usually represented with darker colors. Thus, a visibledifference in contrast will be displayed where there is an interface ofelements or tissues with different echogenicities. As such, providingone or more echogenic elements provide the advantage of providing thephysician the ability to have a real-time enhanced view of the locationand position of the tamponade balloon catheter assembly duringintroduction and placement as well as during use and withdrawal. Thismay also improve patient comfort, success rates, safety, efficiency andresults of a particular procedure.

The echogenic element 19 may be integrally formed with the tamponadeballoon catheter assembly 2. Alternatively, the echogenic element 19 maybe separately formed or manufactured and then attached to the tamponadeballoon catheter assembly 2. Such attachment may be accomplished byadhesives, bonding, over-molding, RF welding, mechanical attachment orother suitable attachment mechanisms. The tamponade balloon catheterassembly 2 may be provided with a single echogenic element 19 or aplurality of echogenic elements 19 as necessary or desired.

In one example, the tamponade balloon catheter assembly 2 may include anechogenic element 19 located at the distal end 15 of the catheter 8. Asshown in FIGS. 2 and 3 , a plurality of echogenic beads 23 are presenton the distal end 15 of catheter 8. In one example, the echogenic beads23 may be formed of glass and may be embedded in a polymeric materialthat is over-molded on to the distal end 15 of the shaft of catheter 8.The polymeric material into which the polymeric beads 23 may beembedded, attached to or otherwise adhered may include rubbers, plasticsand/or other compliant materials that may be over-molded, shaped orformed over the distal end 15 of the catheter 8. In one non-limitingexample, the polymeric material may include silicone. The echogenicbeads 23 may include a molecular coating. Such a molecular coating mayallow the beads 23 to better adhere or bond to the polymeric material,including silicone, to which they are embedded or adhered to. Oneexample of glass echogenic beads 23 are supplied by Potters IndustriesLLC.

It is contemplated that the echogenic beads 23 may be a variety ofshapes, sizes and dimensions. It is also contemplated that the beads 23may be formed by other materials that have echogenic properties. Inother examples, an echogenic element 19, such as a sphere, disk or domewhich may form a single solid echogenic tip on the distal end 15 ofcatheter 8 may be used. One or more additional echogenic elements 19 mayalso be present at one or more locations along the length of thecatheter 8 and/or on the balloon catheter assembly 2. For example,cylindrical bands or other markings that have echogenic properties maybe present on, or applied to, the surface of the catheter 8 and/or theballoon catheter assembly 2.

The echogenic element 19 may be present in varying quantities,percentages, densities or amounts at one or more locations on thetamponade balloon catheter assembly 2. In one example, a greaterpercentage by volume (a higher concentration) of echogenic beads 23 maybe present at the distal end 15 of the catheter 8, which may intensifyultrasound reflection. A greater percentage by volume of the echogenicelement 19 may result in a greater or increased visualization of theparticular portion of the tamponade balloon catheter assembly 2 on whichthe echogenic element 19 is present when viewed under ultrasound. Asshown in FIG. 3 , for example, four distal ends 15 (distal tips) of fourdifferent balloon catheter assemblies are shown as viewed by ultrasound.Each distal end 15 has a different percentage by volume of an echogenicelement 19 present.

More specifically, the four separate distal ends 15 each have adifferent percentage or concentration of echogenic beads 23 that havebeen embedded in a polymeric material and then over-molded on to thedistal end 15 of a tamponade balloon catheter assembly 2. It is the tipof the distal end 15 of each tamponade balloon catheter assembly 2 thatis shown in FIG. 3 . The first (left-most) distal tip has no echogenicelement 19 present. In other words, the distal end 15 has no echogenicbeads 23 or other echogenic element 19 present. The image shown secondfrom left has a 5% by volume concentration of echogenic beads 23embedded in a polymeric material which is over-molded on to the distalend 15 of the catheter 8. The image shown third from left has a 10% byvolume concentration of echogenic beads 23 embedded in a polymericmaterial which is over-molded on to the distal end 15 of the catheter 8.Finally, the image shown on the far right has a 15% by volumeconcentration of echogenic beads 23 embedded in a polymeric materialwhich is over-molded on to the distal end 15 of the catheter 8. In oneexample, the percentage concentration of echogenic beads 23 may be about5% to about 10% by volume concentration of echogenic beads 23 embeddedin silicone which is over-molded on to the distal tip or end 15 of thecatheter 8.

It will be appreciated that a greater or lesser concentration of one ormore echogenic elements 19 may be used as necessary or desired. It willalso be appreciated that different echogenic elements 19 in varyingconcentrations may be located at different positions on or along thetamponade balloon catheter assembly 2. This may depend, for example,upon what portion(s) of the tamponade balloon catheter assembly 2 theuser may wish to increase or enhance visualization by ultrasound duringinsertion and placement of the assembly 2. In one non-limiting example,an echogenic element 19 may be positioned at one or more locations alongthe length of the catheter 8. This may be a single echogenic element 19or more than one. A single echogenic element 19 along the longitudinalbody 9 of the catheter 8 may be larger in size or diameter, while aplurality of echogenic elements 19 may be present at the distal end 15of the tamponade balloon catheter assembly 2 as described above in theform of a plurality of echogenic beads 23.

A tamponade structure, such as a balloon 6, is located near the distalend 15 of the catheter 8, and is preferably made of an expandablematerial such as rubber, silicone, latex or any other expansiblebiocompatible material. Other tamponade mechanisms may also be used inlieu of or in addition to the balloon 6, such as plurality of arms,tubes, loops, mesh or similar structures capable of expanding orotherwise conforming to the uterine cavity 4. As shown generally inFIGS. 6 and 7 , an inflation lumen 14 within the catheter 8 is providedto allow for inflation and deflation of the balloon 6. The inflationlumen 14 may run parallel with the drainage lumen 16, but preferably,the two lumens 14, 16 remain separate for their entire lengths and therespective lumens may generally be the same size and have similar innerdiameters or, alternatively, the respective inflation lumen 14 anddrainage lumen 16 may have different sizes, dimensions and/or innerdiameters.

In one example, as shown in FIGS. 6 and 7 , the drainage lumen 16 may belarger than the inflation lumen 14, such that the inner diameter of thedrainage lumen 16 is shown as being greater than the inner diameter ofthe inflation lumen 14. In one embodiment, the inner diameter of thedrainage lumen may be about 0.215 inches, although other dimensionsgreater or smaller are contemplated. Further, in one example, a septumor separating wall 18 separates the inflation lumen 14 and the drainagelumen 16. The placement of the septum 18 results in each of theinflation lumen 14 and the drainage lumen 16 generally having a “D”shaped cross-section. However, the shape and relative size of therespective lumens 14, 16 can vary, as can the placement of the septum 18that separates the lumens 14, 16, such that the respective lumens canhave approximately the same inner diameter or different inner diametersas necessary or desired.

As shown in at least FIGS. 1, 6 and 8 , the proximal end 13 of thecatheter 8 may include a branch or side arm 20. Alternatively, if a “Y”connector mentioned above is used, this can be one branch of the “Y”connection. As shown in cross-section in FIG. 6 , this side arm 20 is influid communication with the inflation lumen 14. Various media, such aswater, saline, air or other physiologically compatible medium, may beintroduced through the inflation lumen 14 to facilitate controlledexpansion of the balloon 6. When connected to an inflation source, suchas a saline bag, saline filled syringe or other inflation source, theinflation media can be introduced into the inflation lumen 14 throughthe side arm 20 allowing it to flow in a distal direction through thelumen of the catheter 8 and into the balloon 6, thus facilitatingballoon expansion.

Once the balloon 6 has been placed within the uterus 4 of the patient,the balloon 6 may be inflated or otherwise expanded. Preferably, theballoon 6 has sufficient compliance such that, when expanded, itconforms generally to the shape and contour of the cavity in which it isplaced, and when deflated, can be sufficiently reduced in profile toprovide for easy passage and removal through the cervix 7 and vagina 5(or, in the case of a cesarean birth, through the abdominal incision asshown in FIG. 8 ). The size and volume to which the balloon 6 may expandis preferably determined by the body cavity where hemorrhage control isneeded. As shown in FIG. 1 , the balloon 6 is preferably inflated with asufficient volume and pressure such that it conforms generally to thecontours of the uterine cavity 4, and more specifically, to the loweruterine segment. The inflated balloon 6 then exerts a generally uniformcompressive force or pressure upon the uterine wall to substantiallyreduce or even stop the uterine bleeding or hemorrhage. It may also bepossible to coat or impregnate all or at least a portion of the balloonsurface that comes into contact with the uterine wall with biocompatiblematerials, drugs or other substances that may enhance or assist incontrolling uterine bleeding. In one non-limiting example, this mayinclude muscle contracting or clotting enhancing drugs or othersubstances that facilitate inflation/deflation of the balloon 6.

As mentioned above, the tamponade balloon catheter assembly 2 mayinclude one or more other components or accessories. In one example,this may include an introducer device 12. The introducer device 12 maybe integrally formed with and/or coupled to the tamponade ballooncatheter assembly 2. Thus, an assemblage of the tamponade ballooncatheter assembly 2 and the introducer device 12 can be provided to aphysician directly out of the package. Alternatively, the introducerdevice 12 may be a separately provided component that can be insertedinto catheter 8 of the tamponade balloon catheter assembly 2 andremovably coupled to the proximal end 13 of the tamponade ballooncatheter assembly 2 prior to or during use of the tamponade ballooncatheter assembly 2.

The introducer device 12 may comprise a stylet 10 with a hub 22 locatedat the proximal end of the stylet 10, as shown generally in FIGS. 1, 6and 8 . The stylet 10 may provide structure or added rigidity to thecatheter 8 and, as previously mentioned, may be integrally formed withinthe catheter or, alternatively, the stylet 10 may be inserted into thecatheter 8 by a physician prior to or during use of the tamponadeballoon catheter assembly 2. Preferably, the stylet 10 extendslongitudinally within the drainage lumen 16 as shown in FIGS. 6 and 7 ,or alternatively through the inflation lumen 14 or through an additionalor separate lumen of the catheter 8. In one non-limiting example, thestylet 10 may be a solid rod or mandrel as shown in FIGS. 9 and 10 .However, the stylet 10 may be of other shapes or dimensions as necessaryor desired, such as a hollow tube or cannula with a lumen extendingthere through, which provides an additional drainage conduit throughwhich blood or other fluids draining from a body cavity, such as uterus4, can flow.

As shown in FIGS. 4, 5 and 9 in one embodiment, the stylet 10 maycomprise a rod-like structure comprising metals, plastics and/or othermaterials that provide sufficient rigidity to maintain column strengthand bolster the catheter 8, yet still flexible enough to navigate apatient's anatomy. In one example, the stylet 10 may be a stainlesssteel rod. It is also contemplated that the stylet 10 may be formed ofother metals or metal alloys including, for example, shape memory alloysincluding nitinol. The stylet 10 has a proximal end 24, a distal end 26and a middle section 28 located between the proximal and distal ends 24,26. The length of the stylet may be in the range of about 47 cm to about53 cm and preferably about 50 cm, but other suitable lengths arecontemplated as necessary and desired. The outer diameter of the styletmay be about 0.015 inches to about 0.125 inches and, in one example,preferably about 0.04 inches. It is advantageous to provide a stylet 10having a minimal outer diameter such that fluid and/or tissue flowingthrough the drainage lumen 16 can also flow efficiently and freelyaround the outer surface of the stylet 10, when the stylet 10 remains inplace within the drainage lumen 16 of the catheter 8, as shown in FIG. 7. In one example, the outer diameter of the stylet will be less thanhalf (50%) of the inner diameter of the drainage lumen 16. In anotherexample, the outer diameter of the stylet will be less than one quarter(25%) of the inner diameter of the drainage lumen 16. In yet anotherexample, the outer diameter of the stylet will be less than 10% of theinner diameter of the drainage lumen 16. In a further example, the outerdiameter of the stylet will be less than 5% of the inner diameter of thedrainage lumen 16.

The stylet 10 can therefore be left in place within the drainage lumen16 of catheter 8 during use of the tamponade balloon catheter assembly 2to treat hemorrhage. In other words, the introducer device 12 does nothave to be removed from the lumen of the tamponade balloon catheterassembly 2 in order to allow fluid to drain from the uterine cavity 4.However, if necessary or desired, the introducer device 12 can beremoved from the tamponade balloon catheter assembly 2 during use andthen re-inserted into the lumen of the catheter 8 to aid in therepositioning and/or removal of the tamponade balloon catheter assembly2 when hemorrhage ceases and use of the tamponade balloon catheterassembly 2 is complete. Other shapes, dimensions and configurations ofthe stylet 10 are contemplated as necessary to provide the desiredcombination of attributes and characteristics, including, but notlimited to, column strength, stiffness, torsion, flexibility andmalleability of the stylet 10 for the intended use.

The stylet 10 may run the entire length or at least a portion of thelength of the catheter 8, and extend to a location adjacent to or justdistal of the openings 17 at the distal end 15 of the catheter 8, forexample, or at least extend a sufficient length so as to addlongitudinal stability to the catheter 8. Sufficient column strength ofthe stylet 10 provides pushability while reducing or substantiallyeliminating unwanted folding and/or bending of the catheter 8, whilealso resisting and preventing longitudinal shortening, shrinkage and/orcollapse during trans-vaginal insertion (and/or insertion through aC-section incision) and during positioning of the balloon 6 within theuterus 4. The stylet 10 also has sufficient flexibility and malleabilityso as to navigate the contours of a patient's anatomy without causingdamage, perforation, tearing or trauma.

As shown generally in at least FIGS. 4-6 , the introducer device 12 mayfurther comprise a hub portion 22 at the proximal end 24 of the stylet10. The hub 22 comprises a proximal end 30 and a distal end 32 and asidewall 34 extending there between that defines a lumen 40. In oneexample, the outer diameter of the hub 22 may be about 0.313 inches atits distal end 32 at or near where the hub 22 is coupled to the stylet10. The distal end 32 of the hub 22 may be integrally formed with theproximal end 24 of the stylet 10 or it may be separately formed andattached to or over-molded on to the stylet 10 such as by bonding,adhesives and/or other suitable attachment mechanisms. In one example, amolten hub may be over-molded over the proximal end 24 of the stylet 10.In one example, the proximal end 24 of the stylet 10 may be flattenedand/or widened to provide a greater surface area to which the hub 22 maybe over-molded or otherwise attached to the stylet 10 as shown in FIG. 6. The hub 22 may be coaxial with the axis of the stylet 10 or the hub 22may be offset or angled from the proximal end 24 of the stylet 10. Asshown in FIG. 4 , the stylet 10 may extend from one side or wall of thedistal end of the hub. The sidewall 34 of the hub may have a generallyuniform thickness or it may have a varied thickness, with one or moreportions being thicker than other portions. For example, the portion ofthe hub sidewall 34 where the stylet 10 is not attached may be thinnerthan where the stylet 10 attaches to the sidewall 34. The thinnerportion of the sidewall 34 may be about 0.068 inches, while the thickerportion 37 of the sidewall 34 where the stylet 10 attaches to the hub 22may be about 0.120 inches. In one non-limiting example, the thickerportion 37 of the hub sidewall 34 may include about 0.040 inches on oneside of the stylet 10, plus the thickness of the stylet 10 itself being0.040 inches in diameter, and then another thickness of about 0.040inches on the other side of the stylet 10 for a total thickness ofapproximately 0.120 inches. Thus, when viewing the hub 22 in aperspective view as shown in FIG. 4 , the distal end 32 of the hub 22may have an outer diameter of about 0.313 inches which includes thethinner portion of the sidewall 34 of 0.068 inches, plus the diameter ofthe D-shaped hub lumen 40 (which may be approximately 0.125 inches) plusthe 0.120 inch thickness of the thickened portion 37 of the hub sidewall34 where the stylet 10 attaches to the hub 22. These dimensions areexemplary and not intended to be limiting, as other dimensions arecontemplated as one of skill would appreciate. The thickened portion 37of the hub sidewall 34 may provide a sufficient attachment area for thestylet 10 to be attached to the hub 22.

The distal end 26 of the stylet 10 may comprise an atraumatic tip 39.The atraumatic tip 39 reduces or eliminates the risk of scraping,puncturing, tearing or damaging the inner surface of the catheter 8 withthe distal end 26 of the stylet 10 when the introducer device 12 isinserted into the drainage lumen 16. In one example, the distal end 26of the stylet 10 may be over-molded with a softer material, such asrubbers, plastics or other elastomeric materials, so that the distal end26 of the stylet 10 is compliant, soft, bendable and thereforeatraumatic. In another example, the distal end 26 of the stylet 10 maycomprise a sphere, disc, ball or bead or other similar rounded structureformed of metals, plastics, rubbers or combinations of one or morematerials. The ball may be solid or it may include dimples or one ormore holes may be formed therein, similar to a “whiffle ball”configuration. In yet another example shown in FIGS. 9 and 10 , thedistal end 26 of the stylet 10 may be bent or rounded to form a loop,ring, lasso or eyelet type structure. The eyelet shaped distal tip 39shown in FIGS. 9 and 10 may be formed from the same material used toform the stylet 10 or it may be formed of different materials orcombinations thereof.

In one example, the hub 22 may be formed of a biocompatible elastomer,including but not limited to a polymeric molding or casting having adurometer soft enough to be pliable and provide for sealing with othercomponents or fittings (such as a drainage tube 44 and/or drainagefitting 42) yet stiff enough to have pushability during insertion of theintroducer device 12 into the patient during use. The hub 22 may beformed of a polymer such as urethane or silicone or it may be formed ofa co-polymer. Other materials may also be used to form the hub 22including elastomers such as silicone and rubbers and/or plastics. Inone example, the hub 22 may be formed of a nylon blend (such as Pebax®,for example). The hub 22 may have a durometer of approximately 25D toapproximately 40D. It is contemplated that the thicker wall 37 of thehub 22 to which the stylet 10 is attached may be formed of a differentmaterial or an additional material(s), be reinforced or have a differentdurometer than other portions of the hub 22. This could provide astronger, sturdier or more stable portion of the hub 22 to accommodatestylet attachment. The thicker wall 37 may extend the entire length ordistance between the proximal and distal ends 30, 32 of the hub 22 orthe thicker wall 37 may extend only partially between the proximal anddistal ends of the hub 22. As shown in one example in FIG. 6 , thethicker wall ends from the distal end 32 of the hub 22 towards theproximal end 30, where it is coupled to the proximal end 24 of thestylet 10. Further, the thickened portion 37 of the hub sidewall 34 mayextend partially around the circumference of the hub 22. In anotherexample, the thickened portion 37 extends around the entirecircumference of at least a portion of the hub 22.

As illustrated in FIGS. 4-6 , the proximal end 30 of the hub 22 may beflared radially outwardly, such that the proximal end 30 has a greaterouter diameter than the distal end 32 of the hub 22 which may taperradially inwardly. One or more ribs, threads or ridges 38 may be presenton at least a portion of the exterior surface of the hub 22. In onenon-limiting example as shown in FIG. 5 , a plurality of ridges 38extend around the sidewall of the hub 22 in ring-like protrusions, andthe proximal end 30 of the hub 22 comprises a generally smooth surface,free of such ridges 38. The ridges 38 may enhance the gripping surfacefor the user when manipulating the introducer device 12 and/or insertingor removing the hub 22 of the introducer device 12 into and from theproximal end 13 of the catheter 8, while the generally smooth proximalend 30 also provides enhanced stability and structure as well as agripping surface. It should be appreciated that the number of ridges aswell as their shape, (dis)continuity, and relative angle to each otherand the longitudinal axis of the hub 22 are provided as one example,where other configurations will provide a desirable enhanced grippingfunctionality while remaining within the scope of the presentembodiments, yet providing a very different visual appearance. Forexample, the surface could include one or more features instead of or inaddition to the ridges shown and described, such as knurled surfaces;rectangular, hexagonal, or otherwise-cornered geometric-sectionedcircumferential or non-circumferential ribs/ridges that can be straight,zig-zag, or differently oriented; convexly and/or concavely dimpledsurfaces; and other surface configurations known to provide for improvedgripping function.

As shown in FIG. 6 , the tapered distal end 32 of the hub 22 ispreferably shaped for removable attachment or coupling to the proximalend 13 of the catheter 8. For example, the ribbed exterior surface at ornear the distal end 32 of the hub 22 may be inserted into (or otherwiseengaged with, such as by barbs, threads and/or other correspondingengageable surfaces) the proximal end 13 of the catheter 8 as shown inFIG. 6 . In this way, the tamponade balloon catheter assembly 2 and theintroducer device 12 can be coupled and move together as a unit toprovide convenient and efficient insertion, positioning andrepositioning of the tamponade balloon catheter assembly 2 in the uterus4. The distal end 32 of the hub 22 may remain in place within theproximal end 13 of the catheter 8 such as by interference fit orfriction fit or corresponding threads, barbs or sealing surfaces locatedwithin the proximal end 13 of catheter 8, although other methods ofattachment between the respective components may also be used.

The hub 22 may have at least one lumen 40 formed therein. The hub lumen40 may be formed in any portion of the hub 22 between the proximal anddistal hub ends 30, 32, however, as shown in FIG. 4 and FIG. 6 , the hublumen 40 extends between the proximal and distal ends of the hub 22 toallow fluid to flow freely through the hub 22. The hub lumen 40 alsoprovides an aperture into which a drainage fitting 42 can be removablyattached to the proximal end 30 of the hub 22, as shown in FIG. 6 . Inone example, the drainage fitting 42 is a barb fitting but it iscontemplated that any fitting for removable attachment with the hublumen 40 may be used.

Alternatively or in addition to providing a lumen 40 for placement of adrainage fitting 42 during use of the tamponade balloon catheterassembly 2, the hub lumen 40 may also provide an opening for receivingthe inflation port or side arm 20 extending from the proximal end 13 ofthe catheter 8. The side arm 20 can be removably secured within the hublumen 40 of the introducer device 12 as shown in FIG. 8 and FIG. 11 ,such as by friction fit or interference fit, during insertion of thetamponade balloon catheter assembly 2 into the uterus 4 via thetransabdominal approach. The hub 22 may include other openings orapertures in addition to lumen 40 to allow for additional points ofdrainage or inflation and/or to allow additional tubes or catheters tobe removably attached to the hub 22 and placed into fluid communicationwith the catheter 8 when the introducer device 12 is coupled to thetamponade balloon catheter assembly 2 as shown in FIG. 6 .

When the balloon 6 is deployed within the uterine cavity, the outwardforce of the balloon 6 against the uterine wall helps to resistdislodgement of the balloon 6 from the uterus 4. However, the rigidityprovided to the catheter 8 of the tamponade balloon catheter assembly 2by the internal stylet 10 reduces and/or mitigates longitudinal collapseof the catheter 8, such that at least the portion of the catheter 8located between the balloon 6 and the hub 22 of the introducer device 12will maintain structural integrity and longitudinal length. This reducesand/or mitigates longitudinal shrinkage or collapse of the longitudinalcatheter body 9 when force is exerted on it in either a proximal and/ordistal direction, such as in the event that the uterus 4 attempts to“deliver” the balloon 6 through an insufficient cervix (thus exertingpressure on the catheter body 9 in a proximal direction) and/or when aphysician pushes the catheter 8 into the uterus 4 during insertion (thusexerting pressure on the catheter body 9 in a distal direction). Inessence, the stylet 10 provides a scaffold to bolster the catheter 8during introduction, positioning and use of the tamponade ballooncatheter assembly 2.

Turning now to FIGS. 1 and 8 , introduction of a tamponade ballooncatheter assembly 2 such as the Bakri balloon catheter, with anintroducer device 12, may be as described below. Before the uterinetamponade balloon catheter assembly 2 is inserted into a patient, theintroducer device 12 may be inserted into the proximal end 13 of thetamponade balloon catheter assembly 2 and the hub 22 coupled to theproximal end 13 of the tamponade balloon catheter assembly 2.Alternatively, the introducer device 12 may be pre-loaded into thetamponade balloon catheter assembly 2 so that the tamponade ballooncatheter assembly 2 coupled to the introducer device 12 is ready to useas a unit right out of the package. As shown in FIGS. 8 and 11 , theinflation port or side arm 20 at the proximal end 13 of the tamponadeballoon catheter assembly 2 can be inserted into the proximal end 30 ofthe hub 22 and removably secured within the hub lumen 40 of theintroducer device 12 during insertion of the tamponade balloon catheterassembly 2 into the uterus 4, such as by friction fit or interferencefit. In other words, with the hub 22 of the introducer device 12 locatedjust proximal to the proximal end 13 of the tamponade balloon catheterassembly 2, the side arm 20 of the tamponade balloon catheter assembly 2that provides a port for inflation of the balloon 6 during use can betucked into the hub lumen 40 to maintain the tamponade balloon catheterassembly 2 in a low profile and compact delivery configuration toprevent the side arm 20 from interfering with the introduction of thetamponade balloon catheter assembly 2 or from snagging on tissue,especially during a “hub-first” trans-abdominal insertion into theuterus as shown in FIG. 8 .

Following a vaginal birth, the tamponade balloon catheter assembly 2,with the introducer device 12 in place within a lumen of the tamponadeballoon catheter assembly 2, may be inserted “balloon first” through thevagina 5 and into the uterus 4 as shown in FIG. 1 . Alternatively,following a cesarean birth, the tamponade balloon catheter assembly 2,coupled to an introducer device 12 in place within a lumen of thetamponade balloon catheter assembly 2, may be inserted “hub first”through the abdominal incision as shown in FIG. 8 . The hub 22 and theproximal end 13 of the tamponade balloon catheter assembly 2 can bepulled through the vaginal canal until the base of the balloon 6contacts the internal cervical ostium.

With the balloon 6 in its desired position in the uterus 4, the side arm20 can be removed from its position where it has been tucked and heldwithin the hub lumen 40. The balloon 6 may then be inflated or otherwiseexpanded with a physiologically suitable fluid through the inflationlumen 14 of catheter 8. The shape of the fully expanded balloon 6 willgenerally conform to the shape of the interior of the uterus 4, andpreferably the lower uterine segment, thus exerting a compressive forceagainst the uterine walls. In one example, the balloon 6 may be quicklyand carefully inflated with 200 to 500 milliliters of saline. Theballoon 6 may be partially or fully deflated to allow repositioning, ifnecessary. Packing may also be added to the vagina 5, or traction may beapplied to the shaft of the catheter 8 to increase effectiveness of thetamponade balloon catheter assembly 2.

The introducer device 12 may remain in place within the drainage lumen16 of the tamponade balloon catheter assembly 2 during use, if desired.Blood or other fluids draining in a proximal direction through thecatheter 8 from the uterus 4 may flow through the lumen 40 formed in thehub 22 and exit the proximal end 30 of the hub 22 through hub lumen 40.As shown in FIGS. 1 and 6 , a drainage tube 44 is removably attached tothe hub lumen 40 by a drainage adapter fitting 42 that has been insertedinto the hub lumen 40 and is snugly and securely held in place in thehub lumen 40 such as by friction fit, interference fit or other suitableattachment means or mechanisms. The hub 22 is sufficiently pliable andflexible to allow the user to squeeze or otherwise manipulate at leastthe proximal end 30 to open or widen the hub lumen 40 to allow for theease of insertion and removal of a drainage adaptor fitting 42 (as wellas insertion and removal of the side arm 20 as described above) and anyother tubes, adaptors, fittings or accessory devices that the user maywish to place into fluid communication with the hub lumen 40. However,other suitable mechanisms for securing the drainage adaptor fitting 42in place may be used. Blood and other fluids draining proximally throughthe hub 22 can continue flowing through the drainage adaptor fitting 42and into the drainage tube 44 for collection in waste collection bag 11.The volume and flow of fluid into the waste collection bag 11 can bemonitored to determine when hemorrhage is reduced or has ceased. Uponadequate cessation of hemorrhage as determined by the physician, theballoon 6 may be quickly drained through the drainage lumen 16 todeflate the balloon. The tamponade balloon catheter assembly 2 can thenbe removed from the patient trans-vaginally.

Throughout this specification, unless the context requires otherwise,the words “comprise” and “include” and variations such as “comprising”and “including” will be understood to imply the inclusion of an item orgroup of items, but not the exclusion of any other item or group items.

While various embodiments of the invention have been described, it willbe apparent to those of ordinary skill in the art that many moreembodiments and implementations are possible within the scope of theinvention. Furthermore, although various indications have been given asto the scope of this invention, the invention is not limited to any oneof these but may reside in two or more of these combined together.Accordingly, the invention is not to be restricted except in light ofthe attached claims and their equivalents.

1-22. (canceled)
 23. A positioning device comprising: a styletconfigured to be disposed within a catheter lumen and comprising alongitudinal body having a proximal end and a distal end; a hub at theproximal end of the stylet, the hub comprising an open proximal end, anopen distal end and a sidewall extending therebetween defining adrainage hub lumen extending between the open proximal end and the opendistal end; wherein the open proximal end is configured to receiveliquid flow from the hub lumen, through the open proximal end, and outof the open proximal end; wherein the stylet extends from the sidewallof the hub at the distal end of the hub and is radially offset from thelongitudinal axis of the hub.
 24. The positioning device of claim 23,wherein the drainage hub lumen is unobstructed by the stylet.
 25. Thepositioning device of claim 23, wherein the sidewall of the hub is of agenerally uniform thickness.
 26. The positioning device of claim 23,wherein a portion of the sidewall of the hub is thicker than anotherportion of the sidewall of the hub at the distal end of the hub.
 27. Thepositioning device of claim 26, wherein the stylet extends from thethicker portion of the sidewall of the hub at the distal end of the hub.28. The positioning device of claim 26, wherein the lumen of the hub atthe distal end of the hub has a generally D-shape.
 29. The positioningdevice of claim 25, wherein the stylet extends from the sidewall at thedistal end of the hub.
 30. The positioning device of claim 29, whereinthe proximal end of the stylet is embedded within the wall of the hub.31. The positioning device of claim 23, wherein, when the stylet isdisposed within at least a portion of the catheter lumen, the openproximal end remains open.
 32. A positioning device configured for usewith a uterine tamponade catheter, the positioning device comprising: astylet having a longitudinal body having a proximal end and a distalend; a hub at the proximal end of the stylet, the hub comprising an openproximal end, an open distal end and a sidewall extending therebetweendefining a drainage hub lumen extending between the open proximal endand the open distal end; wherein the open proximal end is configured toreceive liquid flow from the hub lumen, through the open proximal end,and out of the open proximal end; wherein the sidewall has a firstthickness and a second thickness; wherein the stylet extends from thesidewall of the hub at the distal end of the hub and is radially offsetfrom the longitudinal axis of the hub such that the drainage hub lumenis unobstructed by the stylet.
 33. The positioning device of claim 32,wherein, when the stylet is disposed within at least a portion of alumen of the uterine tamponade catheter lumen, the open proximal endremains open to provide unobstructed fluid flow from the uterinetamponade catheter lumen, through the drainage hub lumen and out of theopen proximal end.
 34. The positioning device of claim 32, wherein thefirst thickness is greater than the second thickness and extendspartially circumferentially about the distal end of the hub and thestylet extends from the distal end of the hub at the first thickness.35. The positioning device of claim 32, wherein the first thickness andthe second thickness are substantially the same.
 36. The positioningdevice of claim 34, wherein the first thickness extends only partiallybetween the proximal and distal ends of the hub.
 37. The positioningdevice of claim 33, wherein the first thickness is greater than thesecond thickness and extends around the entire circumference of at leasta portion of the hub.
 38. The positioning device of claim 32, whereinthe stylet is configured to be disposed within a portion of a lumen ofthe tamponade catheter, and when the stylet is disposed within theportion of the lumen of the tamponade catheter, the open proximal endremains open.
 39. A system for treating post-partum hemorrhagingcomprising: a positioning device comprising: a stylet having alongitudinal body having a proximal end and a distal end, the styletconfigured to be disposed within a catheter lumen; a hub at the proximalend of the stylet, the hub comprising and open proximal end, an opendistal end, and a sidewall extending therebetween to define a drainagehub lumen extending between the open proximal end and the open distalend; wherein the drainage hub lumen is configured to receive liquid flowfrom the catheter lumen through the open distal end, through thedrainage hub lumen and out of the open proximal end; wherein, the styletextends from the distal end of the hub and is radially offset from thelongitudinal axis of the hub such that the drainage hub lumen isunobstructed by the stylet; and wherein, when the stylet is disposedwithin at least a portion of the catheter lumen, the open proximal endremains open.
 40. The system of claim 39, wherein the stylet extendsfrom the distal end of the hub at the sidewall.
 41. The system of claim39, the stylet extends from a thickened portion of the sidewall.
 42. Thesystem of claim 41, wherein the thickened portion of the sidewallextends only partially circumferentially about the circumference of thedistal end of the hub.